- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417088
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
March 4, 2024 updated by: InSightec
Assessment of Safety and Feasibility of Exablate Type 2 for Blood-Brain Barrier Disruption (BBBD) With Microbubble Resonators for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy
The purpose of this study is to evaluate the safety and feasibility of the Exablate Model 4000 Type 2 system when used as a tool to open the blood-brain-barrier (BBB) in subjects with recurrent glioblastoma (rGBM) undergoing carboplatin monotherapy.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (BBBD) combined with intravenous carboplatin for the treatment of rGBM using the Exablate Neuro Model 4000 Type 2 system with microbubble resonators.
Adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment.
Eligible subjects will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Palo Alto, California, United States, 94304
- Stanford University
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Must be between 18-80 years old
- Histologically confirmed glioblastoma
- Planned for Carboplatin monotherapy
- Be willing and able to provided written informed consent/asent
- Tumor progression after first line chemo radiation
- Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy
- Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception
- Able to communicate verbally
Exclusion Criteria:
- Acute intracranial hemorrhage
- Ferrous metallic implanted objects in the skull or brain
- Prior toxicity with carboplatin chemotherapy
- Women who are pregnant or breastfeeding
- Cerebellar spinal cord or brain stem tumor
- Known active Hepatitis B or Hepatitis C or HIV
- Significant depression not adequately controlled
- Has previously received anti-VEGF or anti-VEGF agents like Avastin
- Cardiac disease or unstable hemodynamics
- Severe hypertension
- History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage
- Active drug or alcohol use disorder
- Known sensitivity to gadolinium-based contrast agents
- Known sensitivity or contraindications to ultrasound contrast agent or perflutren
- Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices
- Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication
- Severely impaired renal function
- Right to left or bi-directional cardiac shunt
- Cranial or systemic infection requiring antibiotics
- Known additional malignancy that is progression or require active treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exablate BBBD with carboplatin
Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles.
The dosage will be calculated based on subject's creatinine level.
On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to Carboplatin administration.
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Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
BBB opening via Exablate Neuro Type 2 system with microbubble resonators.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: Through study completion, an average of 12 months
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All adverse events and/or Serious Adverse Events will be documented and reported according to CTCAE criteria.
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Through study completion, an average of 12 months
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Contrast intensity on MR imaging
Time Frame: Immediately after Exablate BBBD procedure
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BBBD will be determined by contrast intensity in sonicated areas on T1 weighted gadolinium-based MR imaging
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Immediately after Exablate BBBD procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2020
Primary Completion (Actual)
December 31, 2023
Study Completion (Estimated)
July 1, 2024
Study Registration Dates
First Submitted
June 1, 2020
First Submitted That Met QC Criteria
June 3, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BT009
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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